510(k) · Cleared
ClearedPterygoid Indication for GM Helix Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
JJGC Indústria e Comércio de Materiais Dentários S.A. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 12, 2025 as substantially equivalent to K212785 (Blue Sky Bio, LLC, 2022) after a 163-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Dec 12, 2025
- Review
- 163 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K925765 (1993). 74 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 12 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations between
- 3 generations backK160119 NobelSpeedy GroovyNobel Biocare AB · 2016
- 2 generations backK190958 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- 1 generation backK212785 Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant…Blue Sky Bio, LLC · 2022
- This deviceK252090 Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2025
Show all 12 generations
- Root · 12 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 11 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 10 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 9 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 8 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 7 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 6 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 5 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 4 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 3 generations backK160119 NobelSpeedy GroovyNobel Biocare AB · 2016
- 2 generations backK190958 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- 1 generation backK212785 Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant…Blue Sky Bio, LLC · 2022
- This deviceK252090 Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −11 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −10 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −9 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −8 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −7 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −6 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −5 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −4 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| −3 | K160119 | NobelSpeedy Groovy | Nobel Biocare AB | 2016 | — |
| −2 | K190958 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
| −1 | K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue… | Blue Sky Bio, LLC | 2022 | — |
| 0 (this device) | K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Summary page 7…Pterygoid Indication for GM Helix Implants K252090 Predicate Device(s) Primary Predicate: • K212785 – Blue Sky Bio Dental Implant System Reference Devices: • K163194 – Neodent Implant System – GM Line • K19095… | 2022 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K190958 | Neodent Implant System | 2019 |
| † | K190718 | Zygomatic Implants | 2019 |
| † | K232099 | Neodent Implant System - GM Zygomatic Implant System | 2023 |
| † | K182620 | MRI Compatibility for Existing Neodent Implant System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 10 of the 74 ancestors have a recall of any class.
- 2 other devices also cite its predicate K212785.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
GM Helix Implant: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The GM Helix Implant System with…
Read the full statement (474 words)
GM Helix Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The GM Helix Implant System with 3.75 and 4.0 diameter and 18 mm length are indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Implants in the pterygoid indication should be used in splinted applications that utilize at least two implants.
GM Helix LG Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. The GM Helix LG Implant System is indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
GM Mini Conical Abutment 45°:
The Mini Conical Abutments 45° and 60°* are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
GM Mini Conical Abutment 45° Slim:
The Mini Conical Abutments 45° and 52° are indicated for surgical procedures in Zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252090: Pterygoid Indication for GM Helix Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252090
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026